Research ethics

Research ethics is concerned with the moral issues that arise during or as a result of research activities, as well as the conduct of individual researchers, and the implications for research communities.[1] Ethical issues may arise in the design and implementation of research involving human experimentation or animal experimentation. There may also be consequences for the environment, for society or for future generations that need to be considered. Research ethics can be considered as a subfield of applied ethics.

Historically, scandals such as Nazi human experimentation and the Tuskegee syphilis experiment led to the realisation that clear measures are needed for the ethical governance of research to ensure that people, animals and environments are not unduly harmed by scientific inquiry. While there are no universally accepted approach on management of research ethics across countries,[2][3][4] there is a significant body of declarations and treaties and best practices developed. Tipically, research ethics committees (named as institutional review board in the US) have emerged as one governance mechanism to ensure research is conducted responsibly.

Research ethics affect all fields of knowledge that involve human and animal experimentation, from medical research to social sciences. Research ethics is most developed as a concept in medical research, with typically cited codes being the 1947 Nuremberg Code, the 1964 Declaration of Helsinki, and the 1978 Belmont Report. Informed consent is a key concept in research ethics thanks to these codes. Research in other fields such as social sciences, information technology, biotechnology, or engineering may generate different types of ethical concerns to those in medical research.[2][3][5][6][7][8]

Research ethics is commonly distinguished from the promotion of academic or research integrity, which includes issues such as scientific misconduct (e.g. fraud, fabrication of data or plagiarism). Because of the close interaction with integrity, increasingly research ethics is included as part of the broader field of responsible conduct of research (RCR in North America) or Responsible Research and Innovation in Europe, and with government agencies such as the United States Office of Research Integrity or the Canadian Interagency Advisory Panel on Responsible Conduct of Research promoting or requiring interdisciplinary training for researchers.

Legislation

National legislation

In countries such as Canada, mandatory research ethics training is required for students, professors and others who work in research,[9][10] whilst the US has legislated on how institutional review boards operate since the 1974 National Research Act.

Bioethics
This section is an excerpt from Bioethics.[edit]
Bioethics is both a field of study and professional practice, interested in ethical issues related to health (primarily focused on the human, but also increasingly includes animal ethics), including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society (what decisions are "good" or "bad" and why) and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine ("the ethics of the ordinary"), ethical education in science, animal, and environmental ethics, and public health.

Medical ethics
This section is an excerpt from Medical ethics.[edit]

Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice.[11] Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal.[12] It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics.[13] However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation.[14] Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.

There are several codes of conduct. The Hippocratic Oath discusses basic principles for medical professionals.[14] This document dates back to the fifth century BCE.[15] Both The Declaration of Helsinki (1964) and The Nuremberg Code (1947) are two well-known and well respected documents contributing to medical ethics. Other important markings in the history of medical ethics include Roe v. Wade in 1973 and the development of hemodialysis in the 1960s. More recently, new techniques for gene editing aiming at treating, preventing and curing diseases utilizing gene editing, are raising important moral questions about their applications in medicine and treatments as well as societal impacts on future generations,[16][17] yet remain controversial due to their association with eugenics.[18]

As this field continues to develop and change throughout history, the focus remains on fair, balanced, and moral thinking across all cultural and religious backgrounds around the world.[19][20] The field of medical ethics encompasses both practical application in clinical settings and scholarly work in philosophy, history, and sociology.

Medical ethics encompasses beneficence, autonomy, and justice as they relate to conflicts such as euthanasia, patient confidentiality, informed consent, and conflicts of interest in healthcare.[21][22][23] In addition, medical ethics and culture are interconnected as different cultures implement ethical values differently, sometimes placing more emphasis on family values and downplaying the importance of autonomy. This leads to an increasing need for culturally sensitive physicians and ethical committees in hospitals and other healthcare settings.[19][20][24]

Mitigating harm

Ethics committees
This section is an excerpt from Ethics committee.[edit]
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law.

Guidelines for human subject research
This section is an excerpt from Guidelines for human subject research.[edit]
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations.

The main points of the 1931 Guidelines for Human Experimentation are as follows:[Sass, HM. "Reichsrundschreiben 1931: Pre-Nuremberg German Regulations Concerning New Therapy and Human Experimentation," Journal of Medicine and Philosophy 8 (1983): 99-111.]

Full unambiguous and informed consent from test subjects is required, except in extreme extenuating circumstances. Risks should be balanced out by potential benefits. Caution should be taken for subjects under 18 years old. Extreme caution should be taken if microorganisms are involved. Poor or socially disadvantaged subjects should not be exploited. Animal testing should be conducted first, and human experiments are to be avoided if other means of collecting data are still available.

Unethical human experimentation
This section is an excerpt from Unethical human experimentation.[edit]
Unethical human experimentation is human experimentation that violates the principles of medical ethics. Such practices have included denying patients the right to informed consent, using pseudoscientific frameworks such as race science, and torturing people under the guise of research. Around World War II, Imperial Japan and Nazi Germany carried out brutal experiments on prisoners and civilians through groups like Unit 731 or individuals like Josef Mengele; the Nuremberg Code was developed after the war in response to the Nazi experiments. Countries have carried out brutal experiments on marginalized populations. Examples include American abuses during Project MKUltra and the Tuskegee syphilis experiments, and the mistreatment of indigenous populations in Canada and Australia. The Declaration of Helsinki, developed by the World Medical Association (WMA), is widely regarded as the cornerstone document on human research ethics.[25][26][27]

References
  1. Douglas, Heather (2014). "The Moral Terrain of Science". Erkenntnis. 79 (S5): 961–979. doi:10.1007/s10670-013-9538-0. ISSN 0165-0106. S2CID 144445475.
  2. Israel, M. G., & Thomson, A. C. (27–29 November 2013). The rise and much-sought demise of the adversarial culture in Australian research ethics. Paper presented at the 2013 Australasian Ethics Network Conference, Perth, Australia.
  3. Israel, M. (2016). Research ethics and integrity for social scientists: Beyond regulatory compliance (Second ed.). Los Angeles, CA: SAGE.
  4. Eaton, Sarah Elaine (2020). "Ethical considerations for research conducted with human participants in languages other than English". British Educational Research Journal. 46 (4): 848–858. doi:10.1002/berj.3623. ISSN 0141-1926. S2CID 216445727.
  5. Stahl, B. C., Timmermans, J., & Flick, C. (2017). "Ethics of Emerging Information and Communication Technologies On the implementation of responsible research and innovation". Science and Public Policy, 44(3), 369–381.
  6. Iphofen, R. (2016). Ethical decision making in social research: A practical guide. Springer.
  7. Wickson, F., Preston, C., Binimelis, R., Herrero, A., Hartley, S., Wynberg, R., & Wynne, B. (2017). "Addressing socio-economic and ethical considerations in biotechnology governance: The potential of a new politics of care". Food ethics, 1(2), 193–199.
  8. Whitbeck, C. (2011). Ethics in engineering practice and research. Cambridge University Press.
  9. Government of Canada. (n.d.). Panel on Research Ethics: The TCPS2 Tutorial Course on Research Ethics (CORE). Retrieved from http://pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Archived 1 July 2019 at the Wayback Machine
  10. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, & Social Sciences and Humanities Research Council of Canada. (2018). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans: TCPS2 2018. Retrieved from http://www.pre.ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf Archived 28 August 2019 at the Wayback Machine
  11. Beauchamp, J. (2013). "Principles of Biomedical Ethics". Principles of Biomedical Ethics. 7.
  12. Weise, Mary (2016). "Medical Ethics Made Easy". Professional Case Management. 21 (2): 88–94. doi:10.1097/ncm.0000000000000151. PMID 26844716. S2CID 20134799.
  13. "Bioethic Tools: Principles of Bioethics". depts.washington.edu. Archived from the original on 2017-05-10. Retrieved 2017-03-21.
  14. Berdine, Gilbert (2015-01-10). "The Hippocratic Oath and Principles of Medical Ethics". The Southwest Respiratory and Critical Care Chronicles. 3 (9): 28–32–32. doi:10.12746/swrccc.v3i9.185. ISSN 2325-9205.
  15. Riddick, Frank (Spring 2003). "The Code of Medical Ethics of the American Medical Association". The Ochsner Journal. 5 (2): 6–10. PMC 3399321. PMID 22826677.
  16. "Safeguarding the future of human gene editing". login.proxylib.csueastbay.edu. Retrieved 2019-03-19.
  17. Veit, Walter (2018). "Procreative Beneficence and Genetic Enhancement". KRITERION – Journal of Philosophy. 32 (11): 1–8. doi:10.13140/RG.2.2.11026.89289.
  18. Veit, Walter; Anomaly, Jonathan; Agar, Nicholas; Singer, Peter; Fleischman, Diana; Minerva, Francesca (2021). "Can 'eugenics' be defended?". Monash Bioethics Review. 39 (1): 60–67. doi:10.1007/s40592-021-00129-1. PMC 8321981. PMID 34033008.
  19. Coward, Harold G. (1999). A Cross-Cultural Dialogue on Health Care Ethics. Canada: Waterloo, Ont : Wilfrid Laurier university Press. pp. 119–126. ISBN 9780889208551.
  20. Brow, Julie A. (June 2002). "When culture and medicine collide". The Dental Assistant. 71 (3): 26, 28, 36. PMID 12078071.
  21. Appel, JM. Must My Doctor Tell My Partner? Rethinking Confidentiality In the HIV Era, Medicine and Health Rhode Island, Jun 2006
  22. Prah Ruger, Jennifer (October 2014). "Good medical ethics, justice and provincial globalism". J Med Ethics. 41 (1): 103–106. doi:10.1136/medethics-2014-102356. JSTOR 43283237. PMID 25516948.
  23. Güldal D, Semin S (2000). "The influences of drug companies' advertising programs on physicians". Int J Health Serv. 30 (3): 585–95. doi:10.2190/GYW9-XUMQ-M3K2-T31C. PMID 11109183. S2CID 36442226.
  24. Ahmed, Furqaan (August 2013). "Are medical ethics universal or culture specific". World Journal of Gastrointestinal Pharmacology and Therapeutics. 4 (3): 47–48. doi:10.4292/wjgpt.v4.i3.47. PMC 3729866. PMID 23919215.
  25. WMA Press Release: WMA revises the Declaration of Helsinki. 9 October 2000 Archived 27 September 2006 at the Wayback Machine
  26. Snežana, Bošnjak (2001). "The declaration of Helsinki: The cornerstone of research ethics". Archive of Oncology. 9 (3): 179–84.
  27. Tyebkhan, G (2003). "Declaration of Helsinki: the ethical cornerstone of human clinical research". Indian Journal of Dermatology, Venereology and Leprology. 69 (3): 245–7. PMID 17642902.
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